On August 21, 2026 Johnson & Johnson reported that the European Commission (EC) has approved an indication extension for TECVAYLI (teclistamab) in combination with daratumumab for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy. The approval introduces a new treatment option as early as second line for patients living with RRMM.

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Complementary mechanisms of action underpin this immunotherapy doublet

Teclistamab and daratumumab work in a complementary manner, with daratumumab modulating the immune system to enhance T-cell fitness and activation, thereby amplifying teclistamab-mediated killing of myeloma cells.1,2

Expert and company perspectives on advancing the standard of care in RRMM

"Patients with relapsed or refractory multiple myeloma often experience shorter remissions and diminishing responses with each subsequent line of therapy, making earlier access to the most effective treatments increasingly important," said María-Victoria Mateos, M.D., Director of the Myeloma Unit at the University Hospital of Salamanca, Spain. "Today’s approval of teclistamab in combination with daratumumab marks an important advance by providing physicians with an off-the-shelf, steroid-sparing, immunotherapy option that has demonstrated meaningful improvements in progression-free and overall survival, with the potential to redefine treatment expectations as early as second line."

"This new indication for teclistamab plus daratumumab brings forward a new standard of care for patients in Europe living with relapsed or refractory multiple myeloma," said Ester in ‘t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. "By combining the complementary mechanisms of teclistamab, a BCMAxCD3 bispecific antibody, with daratumumab, a well-established standard of care that helps modulate the immune system, we can deliver meaningful long-term outcomes earlier in the treatment journey, where they have the greatest opportunity to influence the disease trajectory and redefine expectations for patients."

"Today’s approval reflects our ongoing commitment to addressing the diverse needs of patients with multiple myeloma, giving them more options at every stage of their disease," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "By continuing to invest in scientific innovation and practice-changing research, we aim to redefine what is possible for patients today, while moving closer to a future where long-term disease control, and ultimately cure, becomes an achievable goal."

Unprecedented Phase 3 study data demonstrate significant survival benefits versus standard of care, representing a potential new benchmark in RRMM

The EC approval is supported by data from the Phase 3 MajesTEC-3 study (NCT05083169), which evaluated the efficacy and safety of teclistamab plus daratumumab subcutaneous (SC) formulation versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (DPd/DVd) in patients with RRMM who have received 1–3 prior lines of therapy.3

Source: Costa L, et al. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. The New England Journal of Medicine 2025; Full article and supplementary material. Available at: View Source Last accessed: August 2026.

The study demonstrated clinically meaningful and statistically significant improvements in both progression-free survival (PFS) and overall survival (OS).1 At nearly three years of follow-up, teclistamab plus daratumumab SC reduced the risk of disease progression or death by 83.4% compared to standard of care (hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.12-0.23; p<0.001).1 More than 90% of patients who remained progression-free at six months (n=249) remained progression-free at three years, highlighting the durability of response observed with this regimen.1 OS favoured teclistamab plus daratumumab SC (HR, 0.46; 95% CI, 0.32-0.65; p<0.0001), with treatment benefit observed across all prespecified subgroups.1,2 At three years, OS rates were 83.3% for the combination compared with 65.0% for standard of care.1

Teclistamab combination demonstrated manageable safety profile

The safety profile of teclistamab plus daratumumab SC was consistent with the well-known profiles of the individual therapies and no new safety signals were identified.1,4,5 All cases of cytokine release syndrome were Grade 1/2 and did not lead to treatment discontinuation.1 Cytopenia and infection were the most commonly observed Grade 3/4 treatment-emergent adverse events (TEAEs).1 Treatment discontinuations due to TEAEs were low and occurred at similar rates between study arms (4.6% [teclistamab] vs. 5.5% [DPd/DVd]).1

About the MajesTEC-3 Study

MajesTEC-3 (NCT05083169) is an ongoing, Phase 3 randomised study evaluating the safety and efficacy of teclistamab plus daratumumab subcutaneous (SC) (n=291) versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (n=296) (DPd/DVd) in patients with relapsed/refractory multiple myeloma (RRMM) who have received 1–3 prior lines of therapy.1,3 The primary endpoint is progression-free survival (PFS) and secondary endpoints include complete response or better (≥CR), overall response rate (ORR), minimal residual disease (MRD) negativity (10⁻⁵ by next-generation sequencing), overall survival (OS), time to worsening of symptoms (MySIm-Q), and safety.3 The MajesTEC-3 study is a part of the MajesTEC clinical programme, which includes exploring the potential of teclistamab as a combination regimen.3

About Teclistamab

Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.6 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.7

Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody.4,8 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer.1,5 Teclistamab is currently being evaluated in several combination studies.4,9,10,11

To date, more than 30,700 patients have been treated worldwide with teclistamab.12

For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: View Source

In line with EMA regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring.4

About Daratumumab and Daratumumab SC

Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease.

In August 2012, Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 830,000 patients worldwide.13 Daratumumab was the first CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma.5,14 Daratumumab SC was also the first oncology injectable approved for administration by patients living with multiple myeloma or their caregivers from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training.5,15 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.5

CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.5,16 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death.5 Daratumumab may also have an effect on normal cells.5 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.17,18,19,20,21,22,23,24,25,26

For further information on daratumumab, please see the Summary of Product Characteristics at: View Source

About Multiple Myeloma

Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.27,28 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.29,30 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2024, and more than 21,900 patients died.31 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter.32,33,34 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.

(Press release, Johnson & Johnson, AUG 21, 2026, View Source [SID1234670280])

On August 21, 2026 Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, reported a strategic licensing and commercialization agreement with Lotus Pharmaceutical (TWSE Stock Code: 1795) covering two of Alvotech’s candidates in the United States and selected Asian markets: AVT34, a proposed biosimilar to Imfinzi (durvalumab), and AVT87, a proposed biosimilar to Hemlibra (emicizumab).

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Imfinzi is an oncology biologic used in the treatment of multiple cancers, which generated global sales of approximately $6.1 billion in 2025¹. Hemlibra is a biologic for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A that generated global sales of approximately CHF4.8 billion (approximately $5.8 billion) in 2025².

Under a semi-exclusive agreement in the United States, Alvotech retains the right to commercialize both products directly alongside Lotus, while Lotus will commercialize the products through Alvogen, its U.S.-based wholly owned subsidiary. Alvotech will retain responsibility for product development, and for obtaining and maintaining marketing authorizations in the United States, and will serve as the exclusive supplier of the products for all markets.

In Asia, Lotus will have exclusive commercialization rights in eight selected markets: South Korea, Taiwan, Thailand, Vietnam, the Philippines, Singapore, Hong Kong and Malaysia. Lotus will be responsible for local regulatory submissions and commercialization in these markets.

The agreement has a potential value to Alvotech of up to approximately $150 million in upfront and milestone payments, in addition to ongoing revenues from the supply of commercial product.

"This agreement represents an important evolution of Alvotech’s commercial strategy," said Lisa Graver, Chief Executive Officer of Alvotech. "For the first time, we will have the opportunity to participate directly in the future commercialization of our products in the United States, allowing us to retain a greater share of the value we create through our development and manufacturing platform. At the same time, our partnership with Lotus extends the potential reach of these two important pipeline assets across key Asian markets. We look forward to working together to bring these medicines to patients and broaden access to high-quality biologics."

"We are pleased to partner with Alvotech on two important biosimilar candidates that meaningfully advance Lotus’ global growth strategy," said Petar Vazharov, Chief Executive Officer of Lotus. "By combining Alvotech’s integrated biosimilar development and manufacturing capabilities with Alvogen’s established U.S. commercial platform and Lotus’s deep market presence across Asia, we are building a strong foundation for the future commercialization of AVT34 and AVT87 across key global markets. These candidates expand the scale and reach of our biosimilar portfolio in oncology and rare diseases, and reinforces our commitment to broadening access to high-quality medicines."

Imfinzi and Hemlibra are registered trademarks and the property of their respective owners.

(Press release, Alvotech, AUG 21, 2026, View Source [SID1234670279])

On August 21, 2026 Dizal (SSE: 688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported that the latest clinical data on its novel epidermal growth factor receptor (EGFR) inhibitor ZEGFROVY (sunvozertinib) in non-small cell lung cancer (NSCLC) will be presented at the 2026 World Conference on Lung Cancer (WCLC) from September 12 to 15 in Seoul, Republic of Korea.

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ZEGFROVY is approved in China and the U.S. for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. In addition, with positive results from WU-KONG28, a multinational randomized Phase 3 study in treatment naïve patients, the Supplemental New Drug Application (sNDA) of ZEGFROVY as first-line treatment has been submitted to China Center for Drug Evaluation (CDE) and the US Food and Drug Administration (FDA). On July 14, Dizal announced that it entered into an exclusive license agreement granting AstraZeneca global rights to develop and commercialize ZEGFROVY. The transaction is expected to close in the second half of 2026.

At WCLC 2026, Dizal will present the latest findings from a study evaluating ZEGFROVY as adjuvant treatment in patients with resected stage IB-IIIB EGFR exon20ins NSCLC. Promising efficacy results strengthen its potential as an earlier treatment option. No new safety signals have been observed. Based on these findings, a randomized pivotal study is ongoing.

In addition, Dizal will report updated data from a Phase 2 study evaluating ZEGFROVY in combination with Anlotinib as first-line treatment for NSCLC with EGFR sensitizing mutations and co-mutations. This oral chemotherapy-free combination regimen continues to exhibit robust anti-tumor activity and a manageable safety profile.

The details of the presentation are shown below:

Lead Author

Abstract Title

Presentation Details

Prof. Chang Chen

Efficacy and Safety of Sunvozertinib as Adjuvant
Treatment in Resected Stage IB-IIIB EGFR Exon 20
Insertion Mutated NSCLC

Abstract Number: P1.159

Poster Session

10:30 AM – 12:00 PM (KST /
UTC +9), Sep 13, 2026

Prof. Yongchang Zhang

Sunvozertinib Plus Anlotinib as First-line Treatment for
NSCLC with EGFR Sensitive Mutations and Co-
mutations: Updated Phase II Data

Abstract Number: P3.207

Poster Session

9:30 AM – 11:00 AM (KST /
UTC +9), Sep 15, 2026

About ZEGFROVY (sunvozertinib)

ZEGFROVY is an irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. ZEGFROVY is approved in the U.S. and China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. The approval in China is based on the results of the pivotal WU-KONG6 study in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The U.S. approval is supported by the results of WU-KONG1 Part B, a multinational pivotal study investigating the efficacy and safety of ZEGFROVY in the same indication. The sNDA for ZEGFROVY as first-line treatment in NSCLC patients with EGFR exon20ins has been submitted to the China Center for Drug Evaluation (CDE) and US Food and Drug Administration (FDA), supported by WU-KONG28 study results. Both China CDE and the US FDA have granted Breakthrough Therapy Designation to ZEGFROVY in this setting.

In addition, ZEGFROVY also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon20ins. ZEGFROVY showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse events) were Grade 1/2 in nature and clinically manageable.

(Press release, Dizal Pharma, AUG 21, 2026, View Source [SID1234670278])

On August 21, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that its investigational next-generation B7-H3-targeting antibody-drug conjugate (ADC), AK157D1, has received clinical trial clearance from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The clearance allows initiation of a Phase I study in patients with advanced malignant solid tumors. Development of AK157D1 in combination with Akeso’s proprietary bispecific antibodies ivonescimab and cadonilimab is also planned.

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AK157D1 is the third next-generation ADC candidate from Akeso to enter clinical development, following AK146D1 (TROP2/Nectin-4 ADC) and AK138D1 (HER3 ADC). The clearance further advances the Company’s IO2.0 + ADC2.0 strategy and expands its broad innovative oncology pipeline.

B7-H3 is highly expressed in a broad range of solid tumors, including non-small cell lung cancer, small cell lung cancer, prostate cancer, esophageal cancer, nasopharyngeal carcinoma, colorectal cancer, breast cancer, and glioblastoma, with limited expression in normal tissues. This profile supports its potential as a broad-spectrum antitumor target.

AK157D1 was developed entirely in-house and incorporates a proprietary design. In preclinical studies, it has shown potent antitumor activity together with a favorable safety profile. These attributes may help address certain limitations associated with existing ADCs, including hematologic toxicity and interstitial lung disease, and support its continued development as a potential ADC of choice in both mono or combination therapies.

Akeso is advancing its IO2.0 + ADC2.0 strategy, built on proprietary bispecific and multispecific antibody technology and centered on cornerstone IO2.0 assets including ivonescimab and cadonilimab. Through this approach, the company is elevating treatment standards for major cancers worldwide and building a broad oncology portfolio to create next-generation standard of care.

In the immuno-oncology field, Akeso has two approved bispecific antibodies for cancer treatment. The Company is actively evaluating ivonescimab and cadonilimab in combination with its proprietary next-generation ADC candidates. Increasingly, global partners recognize both ivonescimab and cadonilimab as preferred agents for combination regimens and breakthrough therapy explorations across a wide spectrum of tumor types. In the ADC space, Akeso has built a differentiated pipeline of next-generation candidates, including AK146D1 and AK138D1, which are already in clinical development, and AK157D1 and AK158D1 (a bispecific ADC), which are anticipated to enter the clinic shortly. These agents are designed to address the narrow therapeutic window and safety limitations commonly associated with first-generation ADCs.

About AK157D1

AK157D1 is a novel B7-H3-targeting ADC independently developed by Akeso. It comprises a recombinant humanized IgG1/κ monoclonal antibody site-specifically conjugated to Dxd, a camptothecin-derived topoisomerase I inhibitor, via a maleimidocaproyl-alanine-alanine-alanine (MC-AAA) linker to interchain cysteine residues. Preclinical studies have demonstrated potent antitumor activity and a favorable safety profile.

(Press release, Akeso Biopharma, AUG 21, 2026, View Source [SID1234670277])

On August 21, 2026 3S Bio (01530.HK) reported its interim results for the first half of 2026. During the period, the Company recorded revenue of RMB 4.53 billion, representing a year-over-year growth of 3.9%. Net profit attributable to equity holders of the Company reached RMB 1.15 billion, and adjusted operating net profit attributable to shareholders of the parent stood at RMB 1.44 billion, up 26.5% year-over-year. R&D expenses amounted to RMB 680 million, an increase of 24.9% year-over-year. The Company’s financial resources totaled RMB 19.4 billion, providing a solid foundation for R&D investments and strategic initiatives. During the first half of the year, marketing approvals for core products were obtained in 23 countries globally, and overseas product sales surged by 43% year-over-year, primarily driven by the increasing market penetration of products such as rhEPO, Yisaipu, and rhTPO in multiple emerging economies.

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Since the beginning of 2026, three Class 1 innovative drugs have been approved for marketing, and five products have advanced to the New Drug Application stage. The Company has successfully constructed a multi-therapeutic pipeline matrix, further consolidating its global competitiveness and advantages in core therapeutic areas. 3SBio has made significant progress in global partnerships, innovative R&D, and product commercialization, marching steadily toward high-quality development.

I. Global Multi-Center Clinical Trials of PF-08634404 (SSGJ-707) Progressing Concurrently

PF-08634404 (SSGJ-707) is an anti-PD-1/VEGF bispecific antibody independently developed by 3SBio, widely recognized as a highly promising next-generation immuno-oncology therapeutic. In 2025, 3SBio granted Pfizer the global development and commercialization rights to SSGJ-707, with a total potential deal value exceeding US$6 billion. The Company is also entitled to receive tiered, double-digit royalties based on cumulative global net sales. Notably, the US$1.4 billion upfront payment and US$100 million equity investment set a new record for the upfront payment of a single out-licensing transaction for a Chinese innovative drug. During the reporting period, the Company recognized RMB 850 million in Business Development revenue.

In 2026, Pfizer is fully accelerating the global multi-center clinical development of SSGJ-707. Nine global multi-center clinical trials have been initiated, covering multiple high-incidence cancers, including squamous/non-squamous non-small cell lung cancer, metastatic colorectal cancer, extensive-stage small cell lung cancer, gastroesophageal cancer, hepatocellular carcinoma, metastatic urothelial carcinoma, and renal cell carcinoma. Among these, two trials have advanced to Phase III, three are in Phase II, and four are in Phase I. As of August 19, 11 clinical trials for SSGJ-707 have been registered, activating over 1,361 clinical sites and expecting to enroll 5,016 patients across 23 countries and regions. Notably, 75 clinical sites in China are participating in nine clinical protocols, ranking second globally, behind only the United States. The Phase III trials cover a target patient population of 225,000 in the U.S., underpinning its subsequent commercial potential. Moving forward, the indication expansions and combination therapy regimens for SSGJ-707 will be continuously explored to fully unlock its global clinical value and commercial growth potential.

II. Intensive Realization of Innovation Value, Building New Growth Engines

In the first half of 2026, 3SBio saw a wave of concentrated milestones across its innovative pipeline. Three Class 1 innovative drugs were successively approved for marketing, and five products progressed to the NDA stage, rapidly translating innovative momentum into performance drivers.

Three internally developed Class 1 innovative biologics were approved for marketing:

Yisaituo (amdokitug injection) was approved in February, indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. With core advantages including robust and rapid clearance of skin lesions, low immunogenicity, favorable safety and tolerability profile, and convenient administration, Yisaituo is poised to reshape psoriasis treatment expectations. The product is expected to further broaden its clinical applications in autoimmune diseases as new indications are continuously developed.

NuPIAO (loncipetin alfa injection) was approved for marketing in March 2026 as the first long-acting recombinant EPO biweekly formulation in China, indicated for the treatment of anemia in hemodialysis patients with chronic kidney disease. The product features an ultra-long half-life of 120 hours and low immunogenicity. The intravenous administration route is highly suitable for hemodialysis patients, and the "once every two weeks" dosing regimen significantly improves patient compliance and convenience.

Yisaina (anflekitug injection) was approved in August, as the first self-developed IgG1/κ humanized anti-IL-1β monoclonal antibody in China, indicated for the treatment of acute gouty arthritis in adults. The product offers differentiated clinical value with rapid pain relief, long-lasting prevention of recurrence, and a favorable safety profile, serving as a preferred alternative to traditional corticosteroid therapy and a novel precision anti-inflammatory option for gout.

Five products in the NDA stage are poised for launch: 3SBio has established a robust pipeline of five products currently under NDA review, covering therapeutic areas such as atopic dermatitis, ophthalmology, breast cancer, and weight management. Among them, NDAs have been accepted for 611 (anti-IL-4Rα mAb) for moderate-to-severe atopic dermatitis in adults, and 601A (anti-VEGF mAb) for macular edema following branch retinal vein occlusion. In-licensed products, including Liporaxel Paclitaxel Oral Solution for HER2-negative breast cancer, DB-1303 (HER2 ADC) for HER2-positive breast cancer, and WS2403 (GLP-1 receptor agonist) for chronic weight management in overweight or obese adults, have also advanced to the NDA stage. These products are expected to be approved sequentially, providing substantial product reserves for the Company’s sustainable growth.

III. Constructing a Multi-Therapeutic Pipeline Matrix to Solidify Long-Term Core Competitive Advantages

3SBio’s R&D pipeline continues to expand, featuring 25 key investigational drug candidates across core therapeutic areas including hemoncology, autoimmune diseases, nephrology, dermatology, and weight management.

Hemato-oncology: Strategic layout of bispecific antibodies/fusion proteins to establish differentiated advantages. TPIAO (recombinant human thrombopoietin injection) has been cleared by the U.S. FDA to initiate a global multi-center bridging clinical trial for the treatment of thrombocytopenia associated with chronic liver disease. 705 (anti-PD-1/HER2 bispecific antibody) has entered Phase II clinical trials for HER2-positive solid tumors, standing as the only drug with this target actively advancing in clinical stages in China, demonstrating significant differentiation. 706 (anti-PD-1/PD-L1 bispecific antibody) has entered Phase II trials for advanced non-small cell lung cancer and advanced gastrointestinal tumors. 708 (anti-PD-1/TGFβ bispecific antibody), 709 (anti-PD-1/LAG-3 bispecific antibody), and SPGL008 (anti-B7-H3 antibody/IL-15 fusion protein) are all in Phase I clinical trials for solid tumors. SSS57 (long-acting ActRIIB-Ig Trap fusion protein) obtained IND clearance from the U.S. FDA for hematological disorders, marking the first innovative biased bispecific antibody entering clinical trials in China. The hemato-oncology pipeline is being continuously optimized, building a robust reserve of high-quality assets for long-term growth.

Nephrology: Focusing on core unmet needs with a first-in-China novel-target portfolio. SSS55 (C3b bifunctional fusion protein) has entered Phase I trials for paroxysmal nocturnal hemoglobinuria, complement-mediated kidney diseases, and periodontitis, demonstrating Best-In-Class potential. SSS68 (long-acting anti-APRIL/BAFF bispecific antibody) has obtained IND approvals in both China and the U.S. for IgA nephropathy, making it the only long-acting bispecific antibody for this indication to enter clinical trials in China.

Dermatology and Weight Management: Exploring new frontiers and expanding pipelines. WS204 (clascoterone cream) is in Phase III clinical trials for moderate-to-severe acne vulgaris. SSS67 (anti-ActRIIA/ActRIIB bispecific antibody) has entered Phase I trials for overweight/obesity.

Autoimmune Diseases: Multiple candidates entering pivotal trials, leading R&D in China.

Yisaituo (amdokitug injection): Patient enrollment completed for the Phase III trial in ankylosing spondylitis; first patient enrolled in the Phase III trial for non-radiographic axial spondyloarthritis.

Yisaina (anflekitug injection): Dose-exploration Phase II study for intermittent gouty arthritis has been initiated.

610 (anti-IL-5 mAb): Patient enrollment completed for the Phase III trial in severe eosinophilic asthma in adults; Phase III enrollment for severe eosinophilic asthma in adolescents is ongoing.

611 (anti-IL-4Rα mAb): NDA submitted and accepted for moderate-to-severe atopic dermatitis in adults.

626 (anti-BDCA2 mAb): Phase II trials for systemic lupus erythematosus and cutaneous lupus erythematosus are being initiated.

627 (anti-TL1A mAb): Phase II enrollment initiated for ulcerative colitis.

716 (OX40L/IL-31RA bispecific antibody): Obtained IND clearances in both China and the U.S. for atopic dermatitis, with Phase I enrollment initiated.

In the early-stage pipeline, 717 (CD3/BCMA/CD19 humanized trispecific antibody) for systemic lupus erythematosus/lupus nephritis/rheumatoid arthritis, 718 (anti-TL1A/IL-23 bispecific antibody injection) for inflammatory bowel disease, 719 (anti-TSLP/IL-4R bispecific antibody inhaler) for asthma/chronic obstructive pulmonary disease, and 629 (oral IL-23R peptide) for psoriasis/inflammatory bowel disease have all entered the IND or pre-clinical stages, showcasing the Company’s forward-looking, end-to-end strategic layout in the autoimmune field.

IV. ESG Practices Receive Authoritative Recognition, Demonstrating Sustainable Development Capabilities

3SBio has consistently integrated Environmental, Social, and Governance principles into its entire operational and management processes. By continuously refining governance structures, fulfilling social responsibilities, and promoting green operations, the Company has achieved solid results in sustainable development, earning accolades from multiple authoritative platforms. In July 2026, 3SBio’s Wind ESG rating was upgraded to "AA", placing it in the top 3.2% of the biotechnology industry, which fully validates its comprehensive strength in risk management, compliance operations, and corporate social responsibility practices. Concurrently, the Company’s implemented public welfare initiatives were once again recognized as an "Excellent Case of Social Responsibility among Chinese Pharmaceutical Industrial Enterprises", reflecting the industry’s acknowledgment of its dedication to philanthropy and corporate social responsibility.

Dr. Jing LOU, Chairman and Chief Executive Officer of 3SBio, commented:

"In early 2026, the biopharmaceutical sector was designated as a emerging strategic pillar industry in China. Amid the industry’s ongoing shift toward high-quality growth, innovative R&D capabilities have emerged as the core engine driving sustained corporate expansion. Leveraging over 30 years of industry legacy, 3SBio stays true to its fundamental principles while actively pursuing innovation. The Company will continuously increase its R&D investment, deepen its focus on oncology, autoimmune diseases, and nephrology, optimize its R&D pipeline, and strengthen its talent pool. In the first half of this year, multiple approvals of key innovative drugs significantly expanded the Company’s long-term growth prospects. Moving forward, we will continue to accelerate the regulatory approval process for our late-stage pipeline, bringing more innovative drugs with substantial clinical value to serve a broader patient population."

(Press release, 3SBio, AUG 21, 2026, View Source [SID1234670276])